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S a f e t y R e p o r t s S e r i e s N o. 7 0
M a n a g e m e n t S y s t e m S t a n d a r d s :
C o m p a r i s o n b e t w e e n I A E A G S - R - 3 a n d
A S M E N Q A - 1 - 2 0 0 8 a n d N Q A - 1 a - 2 0 0 9 A d d e n d a
This Sa fe t y Repor t compares the r equ i r ements o f IAEA Sa fe t y S tandards Se r i es No . GS -R -3 , The Management Sys tem fo r Fac i l i t i e s and Ac t i v i t i e s , and the Amer i can Soc i e t y o f Mechan ica l Eng inee rs ( A S M E ) Q u a l i t y A s s u r a n c e R e q u i r e m e n t s f o r Nuc lea r Fac i l i t y App l i ca t i ons (ASME NQA-1 -2008 , NQA -1a -2009) . I t i den t i f i e s the s im i l a r i t i e s and d i f f e rences be tween them and p rov i des i n fo rma -t i on and gu idance to ass i s t an o rgan i za t i on i n mee t ing the r equ i rements o f bo th s tandards .
INTERNATIONAL ATOMIC ENERGY AGENCYVIENNA
ISBN 978–92–0–120810–1ISSN 1020–6450
IAEA SAFETY STANDARDS AND RELATED PUBLICATIONS
IAEA SAFETY STANDARDS
Under the terms of Article III of its Statute, the IAEA is authorized to establish or adopt standards of safety for protection of health and minimization of danger to life and property, and to provide for the application of these standards.
The publications by means of which the IAEA establishes standards are issued in the IAEA Safety Standards Series. This series covers nuclear safety, radiation safety, transport safety and waste safety. The publication categories in the series are Safety Fundamentals,Safety Requirements and Safety Guides.
Information on the IAEA’s safety standards programme is available at the IAEA Internet site
http://www-ns.iaea.org/standards/
The site provides the texts in English of published and draft safety standards. The texts of safety standards issued in Arabic, Chinese, French, Russian and Spanish, the IAEA Safety Glossary and a status report for safety standards under development are also available. For further information, please contact the IAEA at PO Box 100, 1400 Vienna, Austria.
All users of IAEA safety standards are invited to inform the IAEA of experience in their use (e.g. as a basis for national regulations, for safety reviews and for training courses) for the purpose of ensuring that they continue to meet users’ needs. Information may be provided via the IAEA Internet site or by post, as above, or by email to Official.Mail@iaea.org.
RELATED PUBLICATIONS
The IAEA provides for the application of the standards and, under the terms of Articles III and VIII.C of its Statute, makes available and fosters the exchange of information relating to peaceful nuclear activities and serves as an intermediary among its Member States for this purpose.
Reports on safety and protection in nuclear activities are issued as Safety Reports, which provide practical examples and detailed methods that can be used in support of the safety standards.
Other safety related IAEA publications are issued as Radiological Assessment Reports, the International Nuclear Safety Group’s INSAG Reports, Technical Reports and TECDOCs. The IAEA also issues reports on radiological accidents, training manuals and practical manuals, and other special safety related publications.
Security related publications are issued in the IAEA Nuclear Security Series.The IAEA Nuclear Energy Series consists of reports designed to encourage and assist
research on, and development and practical application of, nuclear energy for peaceful uses. The information is presented in guides, reports on the status of technology and advances, and best practices for peaceful uses of nuclear energy. The series complements the IAEA’s safety standards, and provides detailed guidance, experience, good practices and examples in the areas of nuclear power, the nuclear fuel cycle, radioactive waste management and decommissioning.
RELATED PUBLICATIONS
www.iaea.org/books
MANAGEMENT SYSTEM STANDARDS: COMPARISON BETWEEN IAEA GS-R-3 AND ISO 9011:2008Safety Reports Series No. 69STI/PUB/1529 (55 pp.; 2012)ISBN 978-92-0-120710-4 Price: €29.00
THE MANAGEMENT SYSTEM FOR FACILITIES AND ACTIVITIESIAEA Safety Standards Series No. GS-R-3STI/PUB/1252 (39 pp.; 2006)ISBN 92–0–106506–X Price: €25.00
APPLICATION OF THE MANAGEMENT SYSTEM FOR FACILITIES AND ACTIVITIESIAEA Safety Standards Series No. GS-G-3.1STI/PUB/1253 (123 pp; 2006)ISBN 92-0-106606-6 Price: €31.00
THE MANAGEMENT SYSTEM FOR NUCLEAR INSTALLATIONSIAEA Safety Standards Series No. GS-G-3.5STI/PUB/1392 (139 pp; 2009)ISBN 978-92-0-103409-0 Price: €35.00
MANAGEMENT OF CONTINUAL IMPROVEMENT FOR FACILITIES AND ACTIVITIES: A STRUCTURED APPROACHIAEA TECDOC Series No. 1491IAEA-TECDOC-1491 (61 pp; 2006)ISBN 92-0-102906-3 Price: €15.00
KEY PRACTICAL ISSUES IN STRENGTHENING SAFETY CULTUREINSAG Series No. 15STI/PUB/1137 (25 pp; 2002)ISBN 92–0–112202–0 Price: €12.50
THE MANAGEMENT SYSTEM FOR TECHNICAL SERVICES IN RADIATION SAFETYIAEA Safety Standards Series No. GS-G-3.2STI/PUB/1319 (51 pp; 2008)ISBN 978-92-0-100308-9 Price: €25.00
THE MANAGEMENT SYSTEM FOR THE PROCESSING, HANDLING AND STORAGE OF RADIOACTIVE WASTEIAEA Safety Standards Series No. GS-G-3.3 STI/PUB/1329 (69 pp; 2006)ISBN 978-92-0-102008-6 Price: €25.00
MANAGEMENT SYSTEM STANDARDS:COMPARISON BETWEEN IAEA GS-R-3
AND ASME NQA-1-2008 ANDNQA-1a-2009 ADDENDA
The following States are Members of the International Atomic Energy Agency:
AFGHANISTANALBANIAALGERIAANGOLAARGENTINAARMENIAAUSTRALIAAUSTRIAAZERBAIJANBAHRAINBANGLADESHBELARUSBELGIUMBELIZEBENINBOLIVIABOSNIA AND HERZEGOVINABOTSWANABRAZILBULGARIABURKINA FASOBURUNDICAMBODIACAMEROONCANADACENTRAL AFRICAN
REPUBLICCHADCHILECHINACOLOMBIACONGOCOSTA RICACÔTE D’IVOIRECROATIACUBACYPRUSCZECH REPUBLICDEMOCRATIC REPUBLIC
OF THE CONGODENMARKDOMINICADOMINICAN REPUBLICECUADOREGYPTEL SALVADORERITREAESTONIAETHIOPIAFINLANDFRANCEGABONGEORGIAGERMANY
GHANAGREECEGUATEMALAHAITIHOLY SEEHONDURASHUNGARYICELANDINDIAINDONESIAIRAN, ISLAMIC REPUBLIC OF IRAQIRELANDISRAELITALYJAMAICAJAPANJORDANKAZAKHSTANKENYAKOREA, REPUBLIC OFKUWAITKYRGYZSTANLAO PEOPLE’S DEMOCRATIC
REPUBLICLATVIALEBANONLESOTHOLIBERIALIBYALIECHTENSTEINLITHUANIALUXEMBOURGMADAGASCARMALAWIMALAYSIAMALIMALTAMARSHALL ISLANDSMAURITANIAMAURITIUSMEXICOMONACOMONGOLIAMONTENEGROMOROCCOMOZAMBIQUEMYANMARNAMIBIANEPAL NETHERLANDSNEW ZEALANDNICARAGUANIGER
NIGERIANORWAYOMANPAKISTANPALAUPANAMAPAPUA NEW GUINEAPARAGUAYPERUPHILIPPINESPOLANDPORTUGALQATARREPUBLIC OF MOLDOVAROMANIARUSSIAN FEDERATIONSAUDI ARABIASENEGALSERBIASEYCHELLESSIERRA LEONESINGAPORESLOVAKIASLOVENIASOUTH AFRICASPAINSRI LANKASUDANSWEDENSWITZERLANDSYRIAN ARAB REPUBLICTAJIKISTANTHAILANDTHE FORMER YUGOSLAV
REPUBLIC OF MACEDONIATUNISIATURKEYUGANDAUKRAINEUNITED ARAB EMIRATESUNITED KINGDOM OF
GREAT BRITAIN AND NORTHERN IRELAND
UNITED REPUBLIC OF TANZANIA
UNITED STATES OF AMERICAURUGUAYUZBEKISTANVENEZUELAVIETNAMYEMENZAMBIAZIMBABWE
The Agency’s Statute was approved on 23 October 1956 by the Conference on the Statute of thIAEA held at United Nations Headquarters, New York; it entered into force on 29 July 1957. ThHeadquarters of the Agency are situated in Vienna. Its principal objective is “to accelerate and enlarge thcontribution of atomic energy to peace, health and prosperity throughout the world’’.
e e e
SAFETY REPORTS SERIES No. 70
MANAGEMENT SYSTEM STANDARDS:COMPARISON BETWEEN IAEA GS-R-3
AND ASME NQA-1-2008 ANDNQA-1a-2009 ADDENDA
INTERNATIONAL ATOMIC ENERGY AGENCYVIENNA, 2012
IAEA Library Cataloguing in Publication Data
Management system standards : comparison between IAEA GS-R-3 and ASME NQA-1-2008 and NAQ-1a-2009 Addenda. — Vienna : International Atomic Energy Agency, 2012.
p. ; 24 cm. — (Safety reports series, ISSN 1020–6450 ; no. 70)STI/PUB/1530ISBN 978–92–0–120810–1Includes bibliographical references.
1. Nuclear facilities — Management. 2. Radiation — Safety measures. 3. Nuclear facilities — Reliability. I. International Atomic Energy Agency. II. Series.
IAEAL 12–00738
COPYRIGHT NOTICE
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Marketing and Sales Unit, Publishing SectionInternational Atomic Energy AgencyVienna International CentrePO Box 1001400 Vienna, Austriafax: +43 1 2600 29302tel.: +43 1 2600 22417email: sales.publications@iaea.org http://www.iaea.org/books
© IAEA, 2012
Printed by the IAEA in AustriaMay 2012
STI/PUB/1530
FOREWORD
IAEA safety standards reflect an international consensus on what constitutes a high level of safety for protecting people and the environment. They often serve as safety regulatory documents. In practice, to be fully effective the IAEA safety standards need to be complemented by industry standards and must be implemented within an appropriate national regulatory infrastructure. The IAEA produces a wide range of technical publications and reports to help Member States in developing this national infrastructure and the associated standards.
IAEA Safety Standards Series No. GS-R-3, The Management System for Facilities and Activities (IAEA GS-R-3), defines the requirements for establishing, implementing, assessing and continually improving a management system. A management system designed to fulfil these requirements integrates safety, health, environmental, security, quality and economic elements. IAEA GS-R-3, together with its supporting Safety Guides, supersedes Safety Series No. 50-C/SG-Q, Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations.
IAEA GS-R-3 requirements are applicable to the management systems of operating organizations, designers and suppliers. Moreover, IAEA GS-R-3 can be used as the basis for the management systems of the relevant regulatory bodies. IAEA GS-R-3 also requires the identification and integration of any requirements formally agreed with interested parties such as regulators, suppliers and customers. These formally agreed requirements can include one or more national and international codes and standards. Quality Assurance Requirements for Nuclear Facility Applications (ASME NQA-1-2008 and NQA-1a-2009Addenda), developed by the American Society of Mechanical Engineers (ASME), is an example of such a standard. It is the ninth edition of the ASME NQA-1 series of nuclear quality assurance level 1 standards, published as ASME NQA-1-2008, with the 2009 1a Addenda, published as ASME NQA-1a-2009.
ASME NQA-1-2008 and NQA-1a-2009 Addenda (referred to hereinafter simply as ASME NQA-1) is a national consensus standard that specifies requirements for a quality assurance programme. The purpose of the quality assurance programme is to achieve safe, reliable and efficient utilization of nuclear energy and management and processing of radioactive materials.
The present publication compares the requirements of IAEA GS-R-3 and ASME NQA-1 and identifies similarities and differences between them. The objective is to provide information and guidance to assist an organization to meet the requirements of both standards. This report extends the guidance developed by the IAEA on making the transition from quality management systems to (integrated) management systems based on IAEA GS-R-3.
In this publication, ‘should’ statements are used to provide guidance based on expert judgement; they do not stem from a consensus of IAEA Member States. The guidance provided does not relieve the users of their responsibility to comply with the requirements of the standards.
The IAEA wishes to thank the contributors to this Safety Report for their efforts and valuable assistance. The IAEA officers responsible for this publication were J. Majola and J.P. Boogaard of the Division of Nuclear Power.
EDITORIAL NOTE
Although great care has been taken to maintain the accuracy of information contained in this publication, neither the IAEA nor its Member States assume any responsibility for consequences which may arise from its use.
The use of particular designations of countries or territories does not imply any judgement by the publisher, the IAEA, as to the legal status of such countries or territories, of their authorities and institutions or of the delimitation of their boundaries.
The mention of names of specific companies or products (whether or not indicated as registered) does not imply any intention to infringe proprietary rights, nor should it be construed as an endorsement or recommendation on the part of the IAEA.
CONTENTS
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11.2. Objective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21.3. Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21.4. Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21.5. Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2. APPLICATION OF IAEA GS-R-3 AND ASME NQA-1 STANDARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1. Objectives of IAEA GS-R-3 and ASME NQA-1 . . . . . . . . . . . 32.2. Scope and approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42.3. Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.1. Management system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334.1.1. Safety culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 334.1.2. Management commitment . . . . . . . . . . . . . . . . . . . . . . . 344.1.3. Satisfaction of interested parties . . . . . . . . . . . . . . . . . . 344.1.4. Organizational policies . . . . . . . . . . . . . . . . . . . . . . . . . . 344.1.5. Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 344.1.6. Responsibility, authority and communication . . . . . . . . 344.1.7. Provision of resources . . . . . . . . . . . . . . . . . . . . . . . . . . 354.1.8. Developing processes . . . . . . . . . . . . . . . . . . . . . . . . . . . 354.1.9. Process management . . . . . . . . . . . . . . . . . . . . . . . . . . . 354.1.10. Generic management system processes . . . . . . . . . . . . 364.1.11. Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364.1.12. Managing organizational change . . . . . . . . . . . . . . . . . 364.1.13. Self-assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364.1.14. Management system review . . . . . . . . . . . . . . . . . . . . . 364.1.15. Non-conformances and corrective and
preventive actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 374.1.16. Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
APPENDIX I: CORRELATION BETWEEN THE REQUIREMENTS OF IAEA GS-R-3 AND THOSE OF ASME NQA-1 . . . . 57
APPENDIX II: CORRELATION BETWEEN THE REQUIREMENTS OF ASME NQA-1 AND THOSE OF IAEA GS-R-3 . . . . 58
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59CONTRIBUTORS TO DRAFTING AND REVIEW . . . . . . . . . . . . . . . . . 61
1. INTRODUCTION
1.1. BACKGROUND
The IAEA Safety Requirements publication on The Management System for Facilities and Activities, IAEA Safety Standards Series No. GS-R-3 [1] (IAEA GS-R-3), defines the requirements for establishing, implementing, assessing and continually improving a management system for facilities and activities that integrates safety, health, environmental, security, quality and economic elements. The IAEA Safety Guides on the Application of the Management System for Facilities and Activities [2] and on The Management System for Nuclear Installations [3], as well as other IAEA Safety Guides specific to technical areas, provide recommendations on how to fulfil the requirements specified in IAEA GS-R-3.
The management systems of operators or organizations that provide nuclear items or products and services must comply with safety requirements, including those prescribed in IAEA safety standards (e.g. IAEA GS-R-3) that are adopted by Member States. The utility or owner/operator of a nuclear facility or installation has the ultimate responsibility to ensure that the management system implemented provides for an adequate level of safety. IAEA GS-R-3 helps an organization to put in place a management system that fosters a strong safety culture and improves safety performance.
As Member States adopt and apply IAEA GS-R-3 requirements, regulatory bodies, operators or organizations providing nuclear items or products and services may be required to comply with the safety requirements in these IAEA standards while maintaining the certification or compliance of their items, products and services under ASME NQA-1-2008 and the 2009 1a Addenda published as ASME NQA-1a-2009 [4] (hereinafter referred to as ASME NQA-1) or other relevant codes and standards. Consequently, an organization may adopt IAEA GS-R-3 and ASME NQA-1 as the basis of its management system. IAEA GS-R-3 requires these requirements to be integrated within one management system. Therefore, the present guidance was developed to assist organizations to satisfy these requirements.
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This publication helps organizations by providing information on the similarities and differences between IAEA GS-R-3 and ASME NQA-1. It complements other IAEA publications1 that compare the requirements of management system standards.
1.2. OBJECTIVE
The objective of this Safety Report is to compare the requirements of IAEA GS-R-3 with those of ASME NQA-1, to identify the similarities and differences between them and to provide information and guidance to assist an organization to meet the requirements of both standards.
1.3. SCOPE
This publication compares the requirements in the following publications:
— IAEA Safety Standards Series No. GS-R-3, The Management System for Facilities and Activities [1];
— ASME NQA-1, Quality Assurance Requirements for Nuclear Facility Applications [4], Part I.
1.4. USERS
This publication is intended for:
— Regulatory bodies and customers who require, through regulation or contract, the management systems for nuclear facilities and activities to comply with the requirements of IAEA GS-R-3 and ASME NQA-1;
— Operators of nuclear facilities and activities who are either legally obliged, or choose as best practice, to implement the requirements of IAEA GS-R-3 and ASME NQA-1;
1 These publications include: IAEA Safety Reports Series No. 69 comparison between IAEA GS-R-3 and ISO 9001:2008 [5], and the comparison between IAEA Safety Series No. 50-C/SG-Q (Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations [6]) and the ISO standards, reported in IAEA-TECDOC-1182 [7] and Quality Standards: Comparison between IAEA 50-C/SG-Q and ISO 9001:2000, IAEA Safety Reports Series No. 22 [8].
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— Suppliers of products or services that are required to be produced in accordance with the requirements of IAEA GS-R-3 and ASME NQA-1.
1.5. STRUCTURE
The present publication is structured as follows: Section 2 provides a general description of the application of, and differences between, the IAEA GS-R-3 and ASME NQA-1 standards. Section 3 describes the extent to which IAEA GS-R-3 addresses ASME NQA-1 requirements and includes a table presenting the two standards and comparing them using the process approach of IAEA GS-R-3. Section 4 describes the extent to which ASME NQA-1 addresses the IAEA GS-R-3 requirements and includes a table presenting the two standards and comparing them using the 18 criteria format of ASME NQA-1 [4], Part I.
Appendix I provides a correlation matrix for IAEA GS-R-3 users showing the correspondence between the requirements in IAEA GS-R-3 and those in ASME NQA-1; Appendix II provides a correlation matrix for ASME NQA-1 users showing the correspondence between the requirements in ASME NQA-1 and those in IAEA GS-R-3.
2. APPLICATION OF IAEA GS-R-3AND ASME NQA-1 STANDARDS
2.1. OBJECTIVES OF IAEA GS-R-3 AND ASME NQA-1
IAEA GS-R-3 defines requirements for an organization to establish, implement, assess and continually improve a management system that integrates safety, health, environmental, security, quality and economic elements to ensure that safety is not compromised. It reflects an international consensus on what constitutes an effective, integrated, safety focused management system for nuclear facilities and activities. It fosters a strong safety culture and improved safety performance in all the activities of the organization.
ASME NQA-1 defines requirements for an organization to establish, implement and assess a quality assurance (QA) programme to achieve nuclear safety. ASME NQA-1 reflects industry experience and current understanding of QA requirements for the safe, reliable and efficient utilization of nuclear energy and management and processing of radioactive materials.
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2.2. SCOPE AND APPROACH
IAEA GS-R-3 and ASME NQA-1 apply to the entire life cycle of nuclear facilities and activities, including siting, design, construction, commissioning, operation and decommissioning. Both standards foster the application of requirements in a manner that is consistent with the relative importance of the item or activity to safety.
IAEA GS-R-3 adopts an integrated management system approach to be applied to all work of the organization. It requires the integration of safety, health, environmental, security, quality and economic elements of the management system to ensure that safety is properly taken into account in all activities. It specifies requirements designed to achieve and enhance safety, while enhancing the satisfaction of interested parties. A management system based on IAEA GS-R-3 includes a process approach to achieve the objectives, and continual improvement of the management system and its processes, in which all safety, quality, environmental, security and economic aspects are integrated to preclude a negative impact on safety. A management system based on IAEA GS-R-3, the objective of which is to achieve and enhance safety, also includes safety culture, grading documentation and human performance. Safety Guides GS-G-3.1 [2] and GS-G-3.5 [3] give detailed guidance on how the requirements of IAEA GS-R-3 can be met.
The ASME NQA-1 approach applies QA requirements to activities that could affect the quality of nuclear material applications and of structures, systems and components of nuclear facilities. Quality assurance requirements are used to develop a QA programme necessary to achieve safe, reliable and efficient utilization of nuclear energy and management and processing of radioactive material.
ASME NQA-1 was originally developed to implement QA requirements for nuclear power plant design and construction in the United States of America. ASME NQA-1 now applies expanded QA requirements to a range of nuclear facilities to address new technologies and safety issues. ASME NQA-1 does not require an integrated management system approach, as is required by IAEA GS-R-3.
2.3. APPLICATION
IAEA GS-R-3 can be used by Member States to set management system requirements for nuclear facilities and activities, to provide assurance that safety can be achieved and enhanced. ASME NQA-1 can be imposed by a regulatory body through regulation or national codes and standards. It can be used by a nuclear facility to meet quality requirements set by a regulatory body. Both IAEA GS-R-3 and ASME NQA-1 can be invoked by contract, adopted voluntarily, or
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used as the basis for assessing a management system or a QA programme. These standards require that responsibility for the management system and for work carried out under the management system be retained by the organization. Figure 1 provides an example of how the standards can be applied.
Guidance on evaluating existing practices or supplementing the standard is summarized in the text preceding Table 1 in Section 3 and Table 2 in Section 4. In most cases, the IAEA requirements are stated at a higher, process level and the user must determine the need to develop detailed practices for implementation of the ASME NQA-1 [4] requirements. In these cases, it is necessary to compare existing practices with the requirements of ASME NQA-1 [4] to determine additional requirements for compliance.
Requirement path
Compliance or satisfaction path
Regulatory requirements (can include IAEA GS-R-3 and
ASME NQA-1)
REGULATORY BODY
SUPPLIER
Contractual requirements(can include IAEA GS-R-3 and
ASME NQA-1)
OWNER/OPERATOR of NUCLEAR FACILITY
or ACTIVITY
Legal and statutory
e.g. national lawscan include IAEA GS-R-3
GOVERNMENT
requirements
FIG. 1. Application of IAEA GS-R-3 and ASME NQA-1.
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3. EXTENT TO WHICH IAEA GS-R-3 ADDRESSESASME NQA-1 REQUIREMENTS
This section describes the extent to which IAEA GS-R-3 addresses the ASME NQA-1 requirements. It identifies where the requirements are equivalent and provides guidance on how to modify an IAEA GS-R-3 management system to integrate ASME NQA-1 requirements. Table 1 presents the requirements of ASME NQA-1, Part I, on a line-by-line basis, for all 18 requirements, as well as the subparagraphs of each requirement. Immediately adjacent to the ASME NQA-1 requirement, the corresponding IAEA GS-R-3 requirement is presented. In cases where IAEA GS-R-3 does not specifically meet the ASME NQA-1 requirement, guidance is provided on how best to meet the ASME NQA-1 requirement with IAEA GS-R-3 as a basis. Table 1 provides guidance on how the IAEA GS-R-3 user can meet the ASME NQA-1 requirement. The correlation between the requirements in IAEA GS-R-3 and those in ASME NQA-1 is presented in Appendix I.
The following presents those ASME NQA-1 requirements for which there is ‘No corresponding requirement’ in IAEA GS-R-3, as identified in Table 1. The numbering corresponds to the ASME NQA-1 requirement and section.
REQUIREMENT 2: QUALITY ASSURANCE PROGRAMME
2-300 Qualification requirements
ASME NQA-1 requires the organization to designate activities that require qualification. The minimum requirements for personnel to verify quality and to conduct audits are specified in paragraphs 301–305 of this section of the ASME standard.
2-400 Records of qualification
ASME NQA-1 requires the organization to ensure the qualification of inspection, test and lead auditor(s), and to ensure that their certification is in writing according to the requirements specified in this section of the ASME standard.
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REQUIREMENT 3: DESIGN CONTROL
ASME NQA-1 requires the organization to implement requirements for design control. IAEA GS-R-3 does not contain specific requirements for design control, but IAEA GS-R-3 Requirements 5.1–5.10 address development, implementation and management of processes in general, and these also apply to processes for design control.
3-800 Software design control
ASME NQA-1 has a specific requirement for software design control; in IAEA GS-R-3, this is implicitly required by the general requirements for process implementation (see paras 5.1–5.10).
REQUIREMENT 4: PROCUREMENT DOCUMENT CONTROL
4-300 Procurement document review
ASME NQA-1 explicitly requires the organization to implement requirements for the review of procurement documents.
REQUIREMENT 7: CONTROL OF PURCHASED ITEMS AND SERVICES
7-300 Bid evaluation
ASME NQA-1 explicitly requires the organization to implement requirements for bid evaluation including determination of the supplier’s capability.
7-400 Control of supplier generated documents
ASME NQA-1 explicitly requires the organization to implement requirements for the submission and evaluation of supplier generated documents and changes to ensure that they are accomplished in accordance with the procurement document requirements.
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7-700 Commercial grade items and services
ASME NQA-1 requires the organization to implement requirements for the utilization of commercial grade items or services.
7-800 Records
ASME NQA-1 requires the organization to implement requirements for records for the control of purchased items and services. IAEA GS-R-3 specifies the requirements for control of records in general.
REQUIREMENT 8: IDENTIFICATION AND CONTROL OF ITEMS
8-200 Identification methods
ASME NQA-1 requires the organization to implement requirements for the physical identification of items, for how they are to be used to the maximum extent possible and for how they relate to an applicable design or other pertinent specifying document.
8-300 Specific requirements
ASME NQA-1 requires the organization to implement requirements for the control of item identification consistent with the planned duration and conditions of storage.
REQUIREMENT 9: CONTROL OF SPECIAL PROCESSES
ASME NQA-1 requires the organization to implement requirements for the control of special processes.
9-100 Basic
ASME NQA-1 requires the organization to implement requirements for special processes that control or verify the quality of special activities such as welding, heat treatment and non-destructive examination.
8
9-200 Process control
ASME NQA-1 requires the organization to control the defined special processes by instructions, procedures, drawings, checklists or other appropriate means.
9-300 Responsibility
ASME NQA-1 requires the organization to adhere to the approved procedures and processes when performing special processes.
9-400 Records
ASME NQA-1 requires the organization to implement special processes to maintain records, as appropriate, of the qualified personnel, processes and equipment used in each special process.
REQUIREMENT 10: INSPECTION
10-300 Inspection hold points
ASME NQA-1 requires the organization to implement requirements for mandatory inspection hold points beyond which work shall not proceed.
10-400 Inspection planning
ASME NQA-1 requires the organization to identify characteristics to be inspected, methods of inspection, acceptance criteria and methods of sampling during inspection planning.
10-500 In-process inspection
ASME NQA-1 explicitly requires the organization to implement requirements for the inspection of items under construction or otherwise in process, to verify quality.
10-600 Final inspections
ASME NQA-1 explicitly requires the organization to inspect completed items, re-inspect or retest any modified, repaired or replaced item, approve
9
acceptance of the item and review the results of inspection and of the resolution of non-conformances.
10-700 Inspections during operations
ASME NQA-1 requires the organization to plan and execute periodic inspections (e.g. in-service inspections) or surveillance of structures, systems or components, to ensure the continued performance of their required functions.
10-800 Records
ASME NQA-1 requires the organization to establish and maintain inspection records, and identifies minimum contents for these records.
REQUIREMENT 11: TEST CONTROL
11-200 Test requirements
ASME NQA-1 requires the organization to establish test requirements and acceptance criteria.
11-300 Test procedures (other than for computer programs)
ASME NQA-1 requires the organization to ensure that test procedures include or reference the test configuration and test objectives.
11-400 Computer program test procedures
ASME NQA-1 requires the organization to ensure that computer program test procedures provide for demonstrating the adherence of the computer program to documented requirements.
11-500 Test result
ASME NQA-1 requires the organization to document, maintain and evaluate test results, using a responsible authority to ensure that test requirements have been satisfied.
10
11-600 Test records
ASME NQA-1 requires the organization to establish and maintain test records.
REQUIREMENT 12: CONTROL OF MEASURING AND TEST EQUIPMENT
12-300 Calibration and control
ASME NQA-1 requires the organization to calibrate measuring and test equipment using reference standards and control procedures.
12-400 Records
ASME NQA-1 requires the organization to establish and maintain calibration records, including calibration reports and certificates that include the information and data necessary for interpretation of the calibration results and verification of conformance with applicable requirements.
REQUIREMENT 13: HANDLING, STORAGE AND SHIPPING
13-200 Special requirements
ASME NQA-1 requires the organization to specify, provide and verify the existence of special equipment and special protective environments, when required.
13-400 Tools and equipment
ASME NQA-1 requires the organization to use, control, inspect and test special handling tools and equipment.
13-500 Operators
ASME NQA-1 requires the organization to use operators that are experienced and/or trained in the use of special handling and lifting equipment.
11
13-600 Marking or labelling
ASME NQA-1 requires the organization to use marking or labelling, as necessary, to maintain and preserve the item.
REQUIREMENT 17: QUALITY ASSURANCE RECORDS
17-300 Authentication of records
ASME NQA-1 requires the organization to consider documents as valid records only after they have been authenticated.
17-500 Receipt control of records
ASME NQA-1 requires the organization to designate a person or organization responsible for receiving records and to provide a method for controlling the receipt of records.
17-600 Storage
ASME NQA-1 requires the organization to store records at a predetermined location(s) in a manner that minimizes the risk of loss, damage or destruction.
REQUIREMENT 18: AUDITS
18-200 Scheduling
ASME NQA-1 requires the organization to schedule audits.
18-400 Performance
ASME NQA-1 requires the organization to conduct audits against specified requirements, using the examination of objective evidence to determine effective implementation of the requirements.
12
18-500 Reporting
ASME NQA-1 requires the organization to ensure that the lead auditor endorses the audit report and issues it to the audited organization. It also specifies the contents of the audit report.
18-800 Records
ASME NQA-1 specifies requirements for audit records.
The extent to which IAEA GS-R-3 addresses ASME NQA-1 requirements is shown in Table 1. For copyright reasons, the text of ASME NQA-1 is not included in this table. Keywords are included, as appropriate, to help the reader identify the nature of the requirements. Users should refer to ASME NQA-1 for the full text of the requirements.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
1 Organization
1-100 Basic
Keywords:Responsibilities, organizational structure, functional responsibilities, levels of authority, lines of communication.
Requirements in paras 2.8, 3.12 and 3.14.
1-200 Structure and responsibility
201 GeneralKeywords:(a) Management expectations;(b) Quality achieved and maintained by;(c) Quality achievement verified by(d) Sufficient authority, direct access,
organizational freedom, access to work, independence, verification functions.
202 Delegation of work
Requirements in paras 2.1, 2.2, 2.4, 3.12, 3.13, 3.14, 5.7, 5.10 and 6.5.
IAEA GS-R-3 users should address organizational freedom, independence of verification activities and the following verification functions:(1) Identifying quality problems;(2) Initiating, recommending or providing
solutions to quality problems through designated channels;
(3) Verifying implementation of solutions;
13
(4) Ensuring that further processing, delivery, installation or use is controlled until proper disposition of a non-conformance, deficiency or unsatisfactory condition has occurred.
1-300 Interface control
Requirements in paras 5.4, 5.5 and 5.10.
2 Quality assurance programme
2-100 Basic
Keywords:(a) Documented planned,
implemented, maintained;(c) Management assessment.
Requirements in paras 2.1, 2.6, 2.7, 3.8, 4.1, 4.2, 4.4, 4.5 and 6.
IAEA GS-R-3 users should establish the programme at the earliest time consistent with the schedule for accomplishing the activities and provide for special controls, as required by ASME NQA-1 (see notes under 2-200–2-500 for additional details).
2-200 Indoctrination and training
201 Indoctrination
202 Training
Requirements in paras 4.3 and 4.4.
IAEA GS-R-3 users should ensure that the description and introduction of the job responsibilities and authority includes general criteria, technical objectives, requirements of applicable codes and standards, regulatory commitments, company procedures and quality assurance requirements as required by ASME NQA-1. IAEA GS-R-3 users should conduct an introduction and training commensurate with the scope, complexity and importance of the activities, and with the education, experience and proficiency of the person, consistent with the grading requirements in IAEA GS-R-3 paras 2.6 and 2.7.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
14
2-300 Qualification requirements
Keywords:Designate activities that require qualification, written procedures.
301 Non-destructive examination (NDE)
302 Inspection and test
303 Lead auditor
303.1 Communication skills
303.2 Training
303.3 Audit participation
303.4 Examination
303.5 Maintenance of proficiency
303.6 Requalification
304 Auditors
305 Technical specialists
No corresponding requirements.
IAEA GS-R-3 users should ensure that the responsible organization designates those activities that require qualification. The minimum requirements for personnel to verify quality and auditing are specified in paras 301–304 of this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
2-400 Records of qualification
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement.
2-500 Records
Requirement in para. 5.21.IAEA GS-R-3 users should ensure that records of the implementation of introduction and training include one or more of (a) through (c) of this ASME NQA-1 requirement.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
15
IAEA GS-R-3 users should establish and maintain records of auditor and lead auditor qualification and requalification, and of inspection and test personnel qualification and requalification.
3 Design control
3-100 Basic
Keywords:Defined, controlled.
No corresponding specific requirement.
IAEA GS-R-3 paras 5.1–5.10 address process management in general. IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
3-200 Design input
No corresponding specific requirement.
IAEA GS-R-3 para. 5.4 addresses process inputs. IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
3-300 Design process
Keywords:(a) Prescribe and document the design activities, (b) design methods and (c) final design, commercial grade items and services.
No corresponding specific requirement.
IAEA GS-R-3 para. 5.14 addresses control of products. IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
3-400 Design analyses
401 Use of computer programs
402 Documentation of design analyses
No corresponding specific requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
16
3-500 Design verification
501 Methods
501.1 Design reviews
501.2 Alternate calculations
501.3 Qualification tests
No corresponding specific requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
3-600 Change control
Keywords:(a) Changes to design justified, evaluation of effects, approved, approving organization, demonstrated competence, (c) incorrect design.
601 Configuration management of operating facilities
No corresponding specific requirement.
IAEA GS-R-3 para. 5.13 addresses changes to documents. IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
3-700 Interface control
Keywords:Responsibility, procedures, design information.
No corresponding specific requirement.
IAEA GS-R-3 para. 5.5 addresses the control of interfaces generally. IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
3-800 Software design control
801 Software design process
801.1 Identification of software design requirements
801.2 Software design
801.3 Implementation of the software design
801.4 Software design verification
801.5 Computer program testing
No corresponding requirements.
IAEA GS-R-3 paras 5.3, 5.9 and 5.10 address process management in general. IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
17
802 Software configuration management
802.1 Configuration identification
802.2 Configuration change control
802.3 Configuration status control
3-900 Documentation and records
Keywords:Sources of design inputs.
No corresponding specific requirement.
IAEA GS-R-3 paras 5.6–5.10 address process management generically. These generic requirements address process documentation and records to demonstrate the achievement of process results. IAEA GS-R-3 paras 5.12 and 5.13 address document control, and paras 5.21 and 5.22 address records. IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
4 Procurement document control
4-100 Basic
Keywords:Design bases, suppliers, quality assurance programme.
Requirements in paras 5.23 and 5.24.
IAEA GS-R-3 users should ensure that design bases are addressed in the documents, if applicable.
4-200 Content of the procurement documents
Keywords:All tiers of procurement.
201 Scope of work
202 Technical requirements
Requirements in paras 5.24 and 5.25.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Procurement documents should include the scope, technical requirements, quality assurance
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
18
203 Quality assurance programme requirements
204 Right of access
205 Documentation requirements
206 Non-conformances
207 Spare and replacement parts
requirements, purchaser right of access, documentation requirements, non-conformance reporting provisions, and spare and replacement parts. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
4-300 Procurement document review
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement, including documented changes to procurement documents prior to award, to ensure that documents transmitted to a prospective supplier include the appropriate provisions for ensuring that items or services will meet the specified requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
4-400 Procurement document changes
Requirements in paras 5.13 and 5.14.
5 Instructions, procedures and drawings
5-100 Basic
Keywords:Documented, quantitative or qualitative acceptance criteria, detail commensurate with complexity.
Requirements in paras 2.6–2.10, 4.3, 5.6, 5.7 and 5.9.
6 Document control
6-100 Basic
Requirements in paras 5.12 and 5.13.
6-200 Document control
Requirements in paras 2.8, 2.9 and 5.12.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
19
6-300 Document changes
301 Major changes
302 Minor changes
Requirement in para. 5.13.
7 Control of purchased items and services
7-100 Basic
Requirements in paras 5.15, 5.16, 5.23, 5.24 and 6.3.
7-200 Supplier evaluation and selection
Requirements in paras 5.23, 5.24 and 6.3.
IAEA GS-R-3 users should address one or more of the following: supplier’s history, supplier’s current quality records, supplier’s technical and quality capability.
7-300 Bid evaluation
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
7-400 Control of supplier generated documents
No corresponding requirement.
When supplier documents are received, the requirements in IAEA GS-R-3 paras 5.12, 5.21 and 5.24 provide the necessary controls. IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
20
7-500 Acceptance of item or service
501 GeneralKeywords:Supplier shall verify.
502 Methods of acceptance
503 Certificate of conformance
504 Source verification
505 Receiving inspection
506 Post-installation testing
507 Acceptance of services only
Requirements in paras 5.24 and 5.25.
IAEA GS-R-3 users should address paras 503–507 of ASME NQA-1.
7-600 Control of supplier non-conformances
Keywords:(a) evaluation, (b) submittal, (c) disposition, (d) verification, (e) records.
Requirements in paras 5.25 and 6.11–6.16.
IAEA GS-R-3 users should address paras 600(a)–(e) of ASME NQA-1.
7-700 Commercial grade items and services
701 General No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
7-800 Records
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
21
8 Identification and control of items
8-100 Basic
Keywords:Correct and accepted items.
Requirements in paras 5.18 and 5.19.
8-200 Identification methods
201 Item identification
202 Physical identification
No corresponding requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
8-300 Specific requirements
301 Identification and traceability of items
302 Limited life items
303 Maintaining identification of stored items
No corresponding requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
9 Control of special processes
9-100 Basic
Keywords:Welding, heat treating, non-destructive examination, qualified personnel, qualified procedures.
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
9-200 Process control
201 Special processes
202 Acceptance criteria
203 Special requirements
No corresponding requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
22
9-300 Responsibility
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
9-400 Records
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
10 Inspection
10-100 Basic
Requirements in paras 5.7 and 5.15.
IAEA GS-R-3 users should ensure that inspection for acceptance is performed by qualified persons other than those who performed or directly supervised the work.
10-200 Inspection requirements
Requirement in para 5.7.
When specifying inspection requirements and acceptance criteria, IAEA GS-R-3 users should include specified requirements contained in the applicable design documents or other pertinent technical documents approved by the responsible design organization.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
23
10-300 Inspection hold points
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Specified hold points should be indicated in appropriate documents. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
10-400 Inspection planning
401 Planning
402 Sampling
No corresponding requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
10-500 In-process inspection
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
10-600 Final inspections
601 Resolution of non-conformances
602 Inspection requirements
603 Modifications, repairs or replacements
604 Acceptance
No corresponding requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
24
10-700 Inspections during operations
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
10-800 Records
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
11 Test control
11-100 Basic
Keywords:Collect data, verify conformance, demonstrate satisfactory performance.
Requirements in paras 5.7 and 5.15.
IAEA GS-R-3 users should specify characteristics to be tested and test methods to be employed. Test results shall be documented and their conformance with test requirements and acceptance criteria shall be evaluated.
11-200 Test requirements
No corresponding requirement.
IAEA GS-R-3 users should address this NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
11-300 Test procedures (other than for computer programs)
Keywords:Test configuration, test objectives, prerequisites.
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
25
11-400 Computer program test procedures
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
11-500 Test result
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
11-600 Test records
601 Test records
602 Computer program test records
No corresponding requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
12 Control of measuring and test equipment
12-100 Basic
Requirement in para. 5.15.
IAEA GS-R-3 users should address control, calibration at specific periods, adjustment and maintenance of tools, gauges, instruments, and other measuring and test equipment.
12-200 Selection
Requirement in para. 5.15.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
26
12-300 Calibration and control
301 Calibration
302 Reference standards
303 Control
303.1 Application
303.2 Corrective action
303.3 Handling and storage
303.4 Environmental controls
303.5 Pre-calibration checks
303.6 Status indication
304 Commercial devices
No corresponding requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
12-400 Records
401 GeneralKeywords:Status, capability.
402 Reports and certificates
No corresponding requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
13 Handling, storage and shipping
13-100 Basic
Requirements in paras 5.9 and 5.20.
IAEA GS-R-3 users should address cleaning and packaging of items.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
27
13-200 Special requirements
Keywords:Equipment, protective environment.
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1-1 for guidance on implementation of this requirement, as applicable.
13-300 Procedures
Requirements in paras 2.6, 5.9 and 5.20.
13-400 Tools and equipment
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
13-500 Operators
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
13-600 Marking or labelling
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
28
14 Inspection, test and operating status
14-100 Basic
Keywords:Identified, maintained through indicators, authority.
Requirements in paras 5.15 and 5.18.
IAEA GS-R-3 users should address inspection, test and operating status, as required by ASME NQA-1.
15 Control of non-conforming items
15-100 Basic
Requirements in paras 6.11 and 6.12.
IAEA GS-R-3 users should address notification of affected organizations.
15-200 Identification
Requirement in para. 6.12.
IAEA GS-R-3 users should address the use of identification methods not detrimental to the item, on the item, the container or the package.
15-300 Segregation
Requirement in para. 6.12.
IAEA GS-R-3 users should employ precautions to preclude inadvertent use of a non-conforming item in cases where segregation is impractical or impossible due to physical conditions such as size, weight or access limitations.
15-400 Disposition
401 Control
402 Responsibility and authority
403 Personnel
404 Disposition
405 Re-examination
Requirements in paras 6.12 and 6.13.
IAEA GS-R-3 users should address paras 402 and 403 of ASME NQA-1.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
29
16 Corrective action
16-100 Basic
Keywords:Condition adverse to quality, significant.
Requirements in paras 6.14 and 6.15.
IAEA GS-R-3 users should address verification of completed corrective actions.
17 Quality assurance records
17-100 Basic
Requirements in paras 5.6, 5.21 and 5.22.
IAEA GS-R-3 users should address authentication.
17-200 Generation of records
Requirements in paras 5.6 and 5.21.
17-300 Authentication of records
Keywords:(a) valid, (b) electronic.
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
17-400 Classification
401 Lifetime records
402 Non-permanent records
Requirement in para. 5.22.
IAEA GS-R-3 users should address paras 401 and 402 of ASME NQA-1.
17-500 Receipt control of records
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
30
17-600 Storage
601 GeneralKeywords: (a) location, minimize risk, (b) detrimental activities, (c) access, (d) damage.
602 Facility typesKeywords:(602.1) single, (602.2) dual.
603 Temporary storage
No corresponding requirements.
IAEA GS-R-3 users should address these ASME NQA-1 requirements. Consult relevant parts of ASME NQA-1 for guidance on implementation of these requirements.
17-700 Retention
Requirement in para. 5.22.
17-800 Maintenance of records
Keywords:(a) protected, (b) retrievability, (c) methods for record changes, (d) electronic record media, (e) technology changes, (f) duplicated.
Requirement in para. 5.22.
IAEA GS-R-3 users should address (b) through (f) of ASME NQA-1.
18 Audits
18-100 Basic
Requirements in paras 5.9, 6.3, 6.5 and 6.6.
18-200 Scheduling
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
18-300 Preparation
301 Audit plan
302 Personnel
303 Selection of audit team
Requirement in para. 6.4.
IAEA GS-R-3 users should address paras 301 and 303 of ASME NQA-1.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
31
18-400 Performance
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
18-500 Reporting
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
18-600 Response
Requirements in paras 6.6 and 6.14.
IAEA GS-R-3 users should address evaluation of audit responses by or for the auditing organization.
18-700 Follow-up action
Requirements in paras 5.9 and 6.15.
18-800 Records
No corresponding requirement.
IAEA GS-R-3 users should address this ASME NQA-1 requirement. Consult relevant parts of ASME NQA-1 for guidance on implementation of this requirement.
TABLE 1. EXTENT TO WHICH IAEA GS-R-3 ADDRESSES ASME NQA-1 REQUIREMENTS (cont.)
Requirement ASME NQA-1 Notes to aid users of IAEA GS-R-3
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4. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS
This section describes the extent to which ASME NQA-1 addresses the IAEA GS-R-3 requirements. It identifies where the requirements are equivalent and provides guidance on how to modify an ASME NQA-1 QA programme to meet IAEA GS-R-3 requirements. Table 2 lists all five elements of IAEA GS-R-3, as well as the specific requirements of each. In this table, where a particular ASME NQA-1 requirement meets the specific IAEA GS-R-3 requirement, it is so stated. Where no ASME NQA-1 element meets the IAEA GS-R-3 requirement, guidance is provided on how the IAEA GS-R-3 requirement could be met. Where applicable, reference is made to IAEA Safety Guides GS-G-3.1 [2] and GS-G-3.5 [3] for additional guidance on how IAEA GS-R-3 requirements could be met. The correlation between the requirements in ASME NQA-1 and those in IAEA GS-R-3 is presented in Appendix II.
The following presents those IAEA GS-R-3 requirements for which there is ‘No corresponding requirement’ in ASME NQA-1, as identified in Table 2 (see page 37). The numbering in the table corresponds to IAEA GS-R-3.
4.1. MANAGEMENT SYSTEM
IAEA GS-R-3, para. 2.3, requires the following requirements to be identified and integrated into the management system:
— The statutory and regulatory requirements of the Member State;— Any requirements formally agreed with interested parties (also known as
‘stakeholders’);— All other relevant IAEA Safety Requirements publications, such as those on
emergency preparedness and response and on safety assessment;— Requirements from other relevant codes and standards adopted for use by
the organization.
4.1.1. Safety culture
IAEA GS-R-3, para. 2.5, requires the management system to promote and support a strong safety culture. Specific requirements relate to: a common understanding of the key aspects of safety; support to individuals and teams in carrying out tasks safely; reinforcing a learning and questioning attitude; and continual improvement of the safety culture.
33
4.1.2. Management commitment
IAEA GS-R-3, para. 3.2, requires senior management to develop individual values, institutional values and behavioural expectations for the organization to support the implementation of the management system and act as role models in the promulgation of these values and expectations.
IAEA GS-R-3, para. 3.3, requires management at all levels to communicate to individuals the need to adopt these individual values, institutional values and behavioural expectations that have been developed by senior management as well as the need to comply with the requirements of the management system.
IAEA GS-R-3, para. 3.4, requires management at all levels to foster the involvement of all individuals in the implementation and continual improvement of the management system.
4.1.3. Satisfaction of interested parties
IAEA GS-R-3, para. 3.6, requires senior management to consider the expectations of interested parties in the activities and interactions in the processes of the management system. The aim is to enhance the satisfaction of the interested parties without compromising safety.
4.1.4. Organizational policies
IAEA GS-R-3, para. 3.7, requires senior management to develop policies that are appropriate for the activities and facilities of the organization.
4.1.5. Planning
IAEA GS-R-3, para. 3.10, requires senior management to ensure that measurable objectives are established through appropriate processes at various levels of the organization for implementing the organization’s goals, strategies and plans.
IAEA GS-R-3, para. 3.11, requires senior management to ensure that the implementation of the organization’s goals, strategies and plans is regularly reviewed against the measurable objectives and that actions are taken to address deviations from the implementation plans, where necessary.
4.1.6. Responsibility, authority and communication
IAEA GS-R-3, para. 3.13, requires an individual reporting directly to senior management to have specific responsibility and authority for: coordinating the
34
development and implementation of the management system, and its assessment and continual improvement; reporting on the performance of the management system, including its influence on safety and safety culture, and any need for improvement; and resolving any potential conflicts between requirements and within the processes of the management system.
4.1.7. Provision of resources
IAEA GS-R-3, para. 4.1, requires senior management to determine the necessary resources, and to provide those resources to carry out the activities of the organization and to establish, implement, assess and continually improve the management system.
IAEA GS-R-3, para. 4.2, requires that the information and knowledge of the organization be managed as resources.
4.1.8. Developing processes
IAEA GS-R-3, para. 5.2, requires the determination of the sequence and interactions of the processes of the management system needed to achieve the goals, to provide the means to meet all requirements and to deliver the products of the organization.
4.1.9. Process management
IAEA GS-R-3, para. 5.6, requires that an individual be designated for each process. This individual, normally referred to as the process owner, has the authority and responsibility to manage the process. The process owner has the specific authority and responsibility to: develop and document the process and to maintain the necessary supporting documentation; ensure that there is effective interaction between interfacing processes; ensure that process documentation is consistent with any existing documents; ensure that the records required to demonstrate that the process results have been achieved are specified in the process documentation; monitor and report on the performance of the process; promote improvement in the process; and ensure that the process, including any subsequent changes to it, is aligned with the goals, strategies, plans and objectives of the organization.
35
4.1.10. Generic management system processes
IAEA GS-R-3, para. 5.11, requires the development of generic processes in the management system that include communication and managing organizational change.
4.1.11. Communication
IAEA GS-R-3, para. 5.26, requires that information relevant to safety, health, environmental, security, quality and economic goals be communicated to individuals in the organization and, where necessary, to other interested parties.
IAEA GS-R-3, para. 5.27, requires internal communication between the various levels and functions of the organization concerning the implementation and effectiveness of the management system.
4.1.12. Managing organizational change
IAEA GS-R-3, para. 5.28, requires that organizational changes be evaluated and classified according to their importance to safety and their justification.
4.1.13. Self-assessment
IAEA GS-R-3, para. 6.2, requires senior management and management at all other levels in the organization to carry out self-assessments to evaluate the performance of work and the improvement of the safety culture.
4.1.14. Management system review
IAEA GS-R-3, para. 6.8, requires that the management system review cover, but not be limited to: outputs from all forms of assessment; results delivered and objectives achieved by the organization and its processes; non-conformances and corrective and preventive actions; lessons learned from other organizations; and opportunities for improvement.
IAEA GS-R-3, para. 6.9, requires that weaknesses and obstacles be identified, evaluated and remedied in a timely manner.
IAEA GS-R-3, para. 6.10, requires that the management system review identify whether there is a need to make changes to, or improvements in, policies, goals, strategies, plans, objectives and processes.
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4.1.15. Non-conformances and corrective and preventive actions
IAEA GS-R-3, para. 6.16, requires that potential non-conformances that could detract from the organization’s performance be identified using: feedback from other organizations, both internal and external; technical advances and research; the sharing of knowledge and experience; and techniques that identify best practices.
4.1.16. Improvement
IAEA GS-R-3, para. 6.17, requires that opportunities for improvement of the management system be identified and actions to improve the processes be selected, planned and recorded.
IAEA GS-R-3, para. 6.18, requires that plans to improve the management system include the provision of adequate resources. It also requires that improvement actions be monitored through to their completion and that the effectiveness of the improvements be checked.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
2.1–2.10 Management system
General requirement
2.1 A management system shall be established, implemented, assessed and continually improved. It shall be aligned with the goals of the organization and shall contribute to their achievement. The main aim of the management system shall be to achieve and enhance safety by:– Bringing together in a coherent manner all the
requirements for managing the organization;– Describing the planned and systematic actions
necessary to provide adequate confidence that all these requirements are satisfied;
– Ensuring that health, environmental, security, quality and economic requirements are not considered separately from safety requirements, to help preclude their possible negative impact on safety.
Requirements 1 and 2.
ASME NQA-1 users should ensure that health, safety, environmental, security and economic requirements will be implemented as part of continual improvement of the management system.
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2.2 Safety shall be paramount within the management system, overriding all other demands.
No corresponding specific requirement, but Part I, Introduction, addresses the safe utilization of nuclear energy and nuclear material processing.
ASME NQA-1 users should address safety to the extent described by IAEA GS-R-3 to ensure that safety is paramount.
2.3 The management system shall identify and integrate with the requirements contained within IAEA GSR-R-3:– The statutory and regulatory requirements of
the Member State;– Any requirements formally agreed with
interested parties (also known as ‘stakeholders’);
– All other relevant IAEA Safety Requirements publications, such as those on emergency preparedness and response and safety assessment;
– Requirements from other relevant codes and standards adopted for use by the organization.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-G-3.1, paras 2.1–2.6 and appendix I, for guidance on implementation of this requirement.
2.4 The organization shall be able to demonstrate the effective fulfilment of its management system requirements.
Requirement 2, Section 100 (c).
ASME NQA-1 users should address all aspects of management system requirements.
Safety culture
2.5 The management system shall be used to promote and support a strong safety culture by:– Ensuring a common understanding of the key
aspects of safety culture within the organization;
– Providing the means by which the organization supports individuals and teams in carrying out their tasks safely and successfully, taking into account the interaction between individuals, technology and the organization;
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-R-3, paras 2.32–2.36, for guidance on implementation of this requirement.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
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2.5 (cont.) – Reinforcing a learning and questioning attitude at all levels of the organization;
– Providing the means by which the organization continually seeks to develop and improve its safety culture.
Grading the application of management system requirements
2.6 The application of management system requirements shall be graded so as to deploy appropriate resources, on the basis of the consideration of:– The significance and complexity of each
product or activity;– The hazards and the magnitude of the
potential impact (risks) associated with the safety, health, environmental, security, quality and economic elements of each product or activity;
– The possible consequences if a product fails or an activity is carried out incorrectly.
Requirement 2, Section 100 (a), Requirement 5, Part I, Introduction.
ASME NQA-1 users should deploy appropriate resources based on the potential impact associated with the safety, health, environmental, security and economic aspects of the product or activity in the application of the QA programme. See also Part III, Subpart 2A-2, for additional guidance.
2.7 Grading of the application of management system requirements shall be applied to the products and activities of each process.
Requirement 2, Section 100 (a), Requirement 5, Part I, Introduction.Requirement 3, Section 500 (d), Requirement 3, para. 801.4 (b), Requirement 4, para. 203, Requirement 6, Section 300, Requirement 7, para. 501, and Requirement 7, para. 504 are examples of a graded approach.
ASME NQA-1 users should address the potential impact associated with the safety, health, environmental, security and economic aspects of the products and activities of each process in the application of the QA programme. See also Part III, Subpart 2A-2, for additional guidance
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
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Documentation of the management system
2.8 The documentation of the management system shall include the following:– The policy statements of the organization;– A description of the management system;– A description of the structure of the
organization;– A description of the functional
responsibilities, accountabilities, levels of authority and interactions of those managing, performing and assessing work;
– A description of the processes and supporting information that explain how work is to be prepared, reviewed, carried out, recorded, assessed and improved.
Requirements 1 and 2.Other NQA-1 requirements include responsibilities specific to processes and activities.
ASME NQA-1 users should address, in the documentation of the management system, all IAEA GS-R-3 requirements, i.e. policy statements, and safety, health, environmental, security and economic elements.
2.9 The documentation of the management system shall be developed to be understandable to those who use it. Documents shall be readable, readily identifiable and available at the point of use.
Requirements 1, 2, 6 and 17.
2.10 The documentation of the management system shall reflect:– The characteristics of the organization and its
activities;– The complexities of processes and their
interactions.
Requirement 2, Section 100 (a) and Part I, Introduction.
ASME NQA-1 users should address, in the documentation of the management system, the potential impact associated with the safety, health, environmental, security and economic aspects on products in the processes. See also Part III, Subpart 2A-2, for additional guidance.
The organization should identify all processes and their interactions.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
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3.1–3.14 Management responsibility
Management commitment
3.1 Management at all levels shall demonstrate its commitment to the establishment, implementation, assessment and continual improvement of the management system and shall allocate adequate resources to carry out these activities.
Requirement 1 addresses commitment to the establishment and implementation of the QA programme. Requirement 2, Section 100 (c), addresses the assessment of the QA programme.
ASME NQA-1 users should address continual improvement, resource allocation and all other areas of the management system.
3.2 Senior management shall develop individual values, institutional values and behavioural expectations for the organization to support the implementation of the management system and shall act as role models in the promulgation of these values and expectations.
No corresponding requirement.
Requirement 1, para. 201 (a) addresses ‘overall management expectations’ for the QA programme. NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-R-3, paras 3.1–3.7, for guidance on implementation of this ASME NAQ-1 requirement.
3.3 Management at all levels shall communicate to individuals the need to adopt these individual values, institutional values and behavioural expectations as well as to comply with the requirements of the management system.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-R-3, paras 3.1–3.7, for guidance on implementationof this requirement.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
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3.4 Management at all levels shall foster the involvement of all individuals in the implementation and continual improvement of the management system.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-R-3, paras 3.1–3.7, for guidance on implementation of this requirement.
3.5 Senior management shall ensure that it is clear when, how and by whom decisions are to be made within the management system.
Requirement 1.
Satisfaction of interested parties
3.6 The expectations of interested parties shall be considered by senior management in the activities and interactions in the processes of the management system, with the aim of enhancing the satisfaction of interested parties while at the same time ensuring that safety is not compromised.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-R-3, para. 3.8, for guidance on implementation of this requirement.
Organizational policies
3.7 Senior management shall develop the policies of the organization. The policies shall be appropriate to the activities and facilities of the organization.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-R-3, paras 3.10–3.12, for guidance on implementation of this requirement.
Planning
3.8 Senior management shall establish goals, strategies, plans and objectives that are consistent with the policies of the organization.
Requirement 2, Section 100, addresses aspects of planning.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-R-3, paras 3.13–3.16, for guidance on implementation of this requirement.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
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3.9 Senior management shall develop the goals, strategies, plans and objectives of the organization in an integrated manner so that their collective impact on safety is understood and managed.
Requirement 2, Section 100, addresses aspects of planning.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-G-3.1, paras 3.13–3.16, for guidance on implementation of this requirement.
3.10 Senior management shall ensure that measurable objectives for implementing the goals, strategies and plans are established through appropriate processes at various levels in the organization.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-G-3.1, paras 3.13–3.16, for guidance on implementation of this requirement.
3.11 Senior management shall ensure that the implementation of the plans is regularly reviewed against these objectives and that actions are taken to address deviations from the plans where necessary.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-R-3 for guidance on implementation of this requirement.
Responsibility, authority and communication
3.12 Senior management shall be ultimately responsible for the management system and shall ensure that it is established, implemented, assessed and continually improved.
Requirement 1.
ASME NQA-1 users should address continual improvement.
3.13 An individual reporting directly to senior management shall have specific responsibility and authority for:– Coordinating the development and
implementation of the management system, and its assessment and continual improvement;
No corresponding requirement.
ASME NQA-1 users should ensure that an individual reporting directly to senior management has the specific responsibility and authority for
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
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3.13 (cont.) – Reporting on the performance of the management system, including its influence on safety and safety culture, and any need for improvement;
– Resolving any potential conflicts between requirements and within the processes of the management system.
coordinating the development and implementation of the management system and its assessment and continual improvement. Requirement 1, para. 201, and Requirement 2, para. 100 (c), address assessment attributes for the QA programme.
3.14 The organization shall retain overall responsibility for the management system when an external organization is involved in the work of developing all or part of the management system.
Requirement 1, para. 202.
4.1–4.5 Resource management
Provision of resources
4.1 Senior management shall determine and provide the resources necessary to carry out the activities of the organization and to establish, implement, assess and continually improve the management system. Note: ‘Resources’ includes individuals, infrastructure, the working environment, information and knowledge, and suppliers, as well as material and financial resources.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-G-3.1, paras 4.1–4.5, for guidance on implementation of this requirement.
4.2 The information and knowledge of the organization shall be managed as a resource.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-G-3.1, paras 4.1, 4.2 and 4.4, for guidance on implementation of this requirement.
Human resources
4.3 Senior management shall determine the competence requirements for individuals at all levels and shall provide training or take other actions to achieve the required level of competence. An evaluation of the effectiveness of the actions taken shall be conducted. Suitable proficiency shall be achieved and maintained.
Requirement 2.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
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4.4 Senior management shall ensure that individuals are competent to perform their assigned work and that they understand the consequences for safety of their activities. Individuals shall have received appropriate education and training, and shall have acquired suitable skills, knowledge and experience to ensure their competence. Training shall ensure that individuals are aware of the relevance and importance of their activities and of how their activities contribute to safety in the achievement of the organization’s objectives.
Requirement 2.
ASME NQA-1 users should provide training which ensures that individuals understand the consequences for safety of their activities.ASME NQA-1 users should provide training to ensure that individuals are aware of the relevance and importance of their activities and of how their activities contribute to safety in the achievement of the organization’s objectives.
Infrastructure and the working environment
4.5 Senior management shall determine, provide, maintain and re-evaluate the infrastructure and the working environment necessary for work to be carried out in a safe manner and for requirements to be met.
Requirement 2.
5.1–5.29 Process implementation
Developing processes
5.1 The processes of the management system that are needed to achieve the goals, provide the means to meet all requirements and deliver the products of the organization shall be identified, and their development shall be planned, implemented, assessed and continually improved.
Requirement 2, Section 100 (a), and Requirement 5, Section 100, address the elements of processes.
ASME NQA-1 users should address the identification of processes needed to achieve the organization’s goals and the continual improvement of processes.
5.2 The sequence and interactions of the processes shall be determined.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-R-3, paras 5.1–5.9, for guidance on implementation of this requirement.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
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5.3 The methods necessary to ensure the effectiveness of both the implementation and the control of the processes shall be determined and implemented.
Requirement 5, Section 100.
5.4 The development of each process shall ensure that the following are achieved:– Process requirements, such as applicable
regulatory, statutory, legal, safety, health, environmental, security, quality and economic requirements, are specified and addressed.
– Hazards and risks are identified, together with any necessary mitigatory actions.
– Interactions with interfacing processes are identified.
– Process inputs are identified.– The process flow is described.– Process outputs (products) are identified.– Process measurement criteria are established.
Requirement 2, Section 100 (a), and Requirement 5, Section 100, address many of the requirements related to processes in IAEA GS-R-3 para. 5.1.
ASME NQA-1 users should address the identification of hazards and risks together with any necessary mitigating actions and process measurement. Consult IAEA GS-R-3, para. 5.4, for guidance on implementation of this requirement.
5.5 The activities of and interfaces between different individuals or groups involved in a single process shall be planned, controlled and managed in a manner that ensures effective communication and the clear assignment of responsibilities.
Requirement 1, in Sections 100 and 300, addresses functional interfaces.
ASME NQA-1 users should address interfaces between different individuals or groups involved in a single process.
Process management
5.6 For each process a designated individual shall be given the authority and responsibility for:– Developing and documenting the process and
maintaining the necessary supporting documentation;
– Ensuring that there is effective interaction between interfacing processes;
– Ensuring that process documentation is consistent with any existing documents;
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-R-3, paras 5.10–5.23, for guidance on implementation of this requirement.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
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5.6 (cont.) – Ensuring that the records required to demonstrate that the process results have been achieved are specified in the process documentation;
– Monitoring and reporting on the performance of the process;
– Promoting improvement in the process;– Ensuring that the process, including any
subsequent changes to it, is aligned with the goals, strategies, plans and objectives of the organization.
The organization should identify a designated individual for each process.
5.7 For each process, any activities for inspection, testing, verification and validation, their acceptance criteria and the responsibilities for carrying out these activities shall be specified. For each process, it shall be specified if and when these activities are to be performed by designated individuals or groups other than those who originally performed the work.
Requirement 10.
5.8 Each process shall be evaluated to ensure that it remains effective.
Requirement 2, Section 100 (c).
ASME NQA-1 users should ensure that assessment of the adequacy of the QA programme includes assessment of the processes.
5.9 The work performed in each process shall be carried out under controlled conditions, by using approved current procedures, instructions, drawings or other appropriate means that are periodically reviewed to ensure their adequacy and effectiveness. Results shall be compared with expected values.
Requirement 2, Section 100 (c), and Requirement 5.
5.10 The control of processes contracted to external organizations shall be identified within the management system. The organization shall retain overall responsibility when contracting any processes.
Requirement 1, para. 202 and Section 300.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
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Generic management system process
5.11 The following generic processes shall be developed in the management system.
No corresponding requirement.
ASME NQA-1 users should refer to corresponding requirements and notes for IAEA GS-R-3 paras 5.12–5.29.
Control of documents
5.12 Documents shall be controlled. All individuals involved in preparing, revising, reviewing or approving documents shall be specifically assigned this work, shall be competent to carry it out and shall be given access to appropriate information on which to base their input or decisions. It shall be ensured that document users are aware of and use appropriate and correct documents.
Requirement 6.
5.13 Changes to documents shall be reviewed and recorded and shall be subject to the same level of approval as the documents themselves.
Requirement 6, Section 300.
Control of products
5.14 Specifications and requirements for products, including any subsequent changes, shall be in accordance with established standards and shall incorporate applicable requirements. Products that interface or interact with each other shall be identified and controlled.
Requirements 3, 4, 7 and 8.
5.15 Activities for inspection, testing, verification and validation shall be completed before the acceptance, implementation or operational use of products. The tools and equipment used for these activities shall be of the proper range, type, accuracy and precision.
Requirements 8, 10, 11 and 12, and Requirement 13, Section 400.
5.16 The organization shall confirm that products meet the specified requirements and shall ensure that products perform satisfactorily in service.
Requirements 7, 8 and 10.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
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5.17 Products shall be provided in such a form that it can be verified that they satisfy the requirements.
Requirements 7 and 8.
5.18 Controls shall be used to ensure that products do not bypass the required verification activities.
Requirement 7, Section 500, and Requirements 10 and 14.
5.19 Products shall be identified to ensure their proper use. Where traceability is a requirement, the organization shall control and record the unique identification of the product.
Requirements 8 and 14.
5.20 Products shall be handled, transported, stored, maintained and operated as specified, to prevent their damage, loss, deterioration or inadvertent use.
Requirements 8, Section 300, and Requirement 13.
Control of records
5.21 Records shall be specified in the process documentation and shall be controlled. All records shall be readable, complete, identifiable and easily retrievable.
Requirements 6 and 17.
5.22 Retention times of records and associated test materials and specimens shall be established to be consistent with the statutory requirements and knowledge management obligations of the organization. The media used for records shall be such as to ensure that the records are readable for the duration of the retention times specified for each record.
Requirement 17.
ASME NQA-1 users should ensure that records and associated test materials and specimens are consistent with knowledge management.
Purchasing
5.23 Suppliers of products shall be selected on the basis of specified criteria, and their performance shall be evaluated.
Requirement 4 and Requirement 7, Sections 100, 200 and 300.
5.24 Purchasing requirements shall be developed and specified in procurement documents. Evidence that products meet these requirements shall be available to the organization before the product is used.
Requirements 4 and 7.
5.25 Requirements for the reporting and resolution of non-conformances shall be specified in procurement documents.
Requirement 4, para. 206, and Requirement 7, Sections 600 and 700.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
49
Communication
5.26 Information relevant to safety, health, environmental, security, quality and economic goals shall be communicated to individuals in the organization and, where necessary, to other interested parties.
No corresponding requirement.
ASME NQA-1 users should address requirements for the communication of relevant information on safety, health, environmental, security, quality and economic goals. Consult IAEA GS-R-3, paras 5.52–5.55, for guidance on implementation of this requirement.
5.27 Internal communication concerning the implementation and effectiveness of the management system shall take place between the various levels and functions of the organization.
No corresponding requirement.
ASME NQA-1 users should address requirements for internal communication regarding the implementation and effectiveness of the management system. Consult IAEA GS-R-3, paras 5.52–5.55, for guidance on implementation of this requirement.
Managing organizational change
5.28 Organizational changes shall be evaluated and classified according to their importance to safety, and each change shall be justified.
No corresponding requirement.
ASME NQA-1 users should address requirements for the evaluation, classification and justification of organizational changes. Consult IAEA GS-R-3, paras 5.56–5.71, for guidance on implementation of this requirement.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
50
5.29 The implementation of such changes shall be planned, controlled, communicated, monitored, tracked and recorded to ensure that safety is not compromised.
Requirement 1, Section 100, addresses documenting the organizational structure, levelsof authority and lines of communication for the existing organization.
ASME NQA-1 users should address the evaluation, planning, communication and monitoring of organizational change. Consult IAEA GS-R-3, paras 5.56–5.71, for guidance on implementation of this requirement.
6.1–6.18 Measurement, assessment and improvement
Monitoring and measurement
6.1 The effectiveness of the management system shall be monitored and measured to confirm the ability of the processes to achieve the intended results and to identify opportunities for improvement.
Requirement 1, Section 201 (d), and Requirement 2, Section 100 (c), for review and effective implementation of the QA programme.
ASME NQA-1 users should use the results of monitoring activities and management assessment of the adequacy of the QA programme to identify opportunities for improvement.
Self-assessment
6.2 Senior management and management at all other levels of the organization shall carry out self-assessment to evaluate the performance of work and the improvement of the safety culture.
No corresponding requirement.
ASME NQA-1 users should address the requirement for self-assessment by all levels of management. Consult IAEA GS-G-3.1, paras 6.6–6.21 [2], for guidance on implementation of this requirement.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
51
Independent assessment
6.3 Independent assessments shall be conducted regularly on behalf of senior management:– To evaluate the effectiveness of processes in
meeting and fulfilling goals, strategies, plans and objectives;
– To determine the adequacy of work performance and leadership;
– To evaluate the organization’s safety culture;– To monitor product quality;– To identify opportunities for improvement.
Requirements 2 and 18.
ASME NQA-1 users should address the requirements to evaluate safety culture and to identify opportunities for improvement.
6.4 An organizational unit shall be established with the responsibility for conducting independent assessments. This unit shall have sufficient authority to discharge its responsibilities.
Requirements 2 and 18.
6.5 Individuals conducting independent assessments shall not assess their own work.
Requirement 1, Section 200, and Requirement 18.
6.6 Senior management shall evaluate the results of the independent assessments, shall take any necessary actions, and shall record and communicate their decisions and the reasons for them.
Requirements 16 and 18.
Management system review
6.7 A management system review shall be conducted at planned intervals to ensure the continuing suitability and effectiveness of the management system and its ability to enable the objectives set for the organization to be accomplished.
Requirement 2, Section 100 (c), for assessment of the adequacy and effective implementation of the QA programme.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-G-3.1, paras 6.45–6.49 [2], for guidance on implementation of this requirement.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
52
6.8 The review shall cover but shall not be limited to:– Outputs from all forms of assessment;– Results delivered and objectives achieved by
the organization and its processes;– Non-conformances, and corrective and
preventive actions;– Lessons learned from other organizations;– Opportunities for improvement.
No corresponding requirement.
ASME NQA-1 users should ensure that these inputs to management system review are addressed. Consult IAEA GS-G-3.1, para. 6.47 [2], for guidance on implementation of this requirement.
6.9 Weaknesses and obstacles shall be identified, evaluated and remedied in a timely manner.
No corresponding requirement.
ASME NQA-1 users should address the requirement to identify, evaluate and remedy weaknesses and obstacles as part of management system review. Consult IAEA GS-R-3, para. 6.49, for guidance on implementation of this requirement.
6.10 The review shall identify whether there is a need to make changes to or improvements in policies, goals, strategies, plans, objectives and processes.
No corresponding requirement.
ASME NQA-1 users should address the requirement to identify necessary changes or improvements in policies, goals, strategies, plans, objectives and processes as part of management system review.
Non-conformances and corrective and preventive actions
6.11 The causes of non-conformances shall be determined, and remedial actions shall be taken to prevent their recurrence.
Requirements 15 and 16.
ASME NQA-1 users should address the determination of causes of non-conformances for all non-conformances, not just those that are for significant conditions adverse to quality.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
53
6.12 Products and processes that do not conform to the specified requirements shall be identified, segregated, controlled, recorded and reported to an appropriate level of management within the organization. The impact of non-conformances shall be evaluated and non-conforming products or processes shall be either:– Accepted;– Reworked or corrected within a specified time
period;– Rejected and discarded or destroyed to
prevent their inadvertent use.
Requirement 15.
6.13 Concessions granted to allow acceptance of a non-conforming product or process shall be subject to authorization. When non-conforming products or processes are reworked or corrected, they shall be subject to inspection to demonstrate their conformity with requirements or expected results.
Requirement 7, Section 600, and Requirement 15.
6.14 Corrective actions for eliminating non-conformances shall be determined and implemented. Preventive actions to eliminate the causes of potential non-conformances shall be determined and taken.
Requirement 16.
ASME NQA-1 users should address the determination and taking of preventive actions to eliminate the causes of potential non-conformances.
6.15 The status and effectiveness of all corrective and preventive actions shall be monitored and reported to management at an appropriate level of the organization.
Requirement 16.
ASME NQA-1 users should address the requirement to monitor and report on the status and effectiveness of all corrective and preventive actions.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
54
6.16 Potential non-conformances that could detract from the organization’s performance shall be identified. This shall be done: by using feedback from other organizations, both internal and external; through the use of technical advances and research; through the sharing of knowledge and experience; and through the use of techniques that identify best practices.
No corresponding requirement.
ASME NQA-1 users should address the requirement to identify potential non-conformances by using feedback from other organizations, both internal and external; through the use of technical advances and research; through the sharing of knowledge and experience; and through the use of techniques that identify best practices. Consult IAEA GS-G-3.1, paras 6.76–6.77 [2], for guidance on implementation of this requirement.
Improvement
6.17 Opportunities for the improvement of the management system shall be identified and actions to improve the processes shall be selected, planned and recorded.
No corresponding requirement.
ASME NQA-1 users should address this IAEA GS-R-3 requirement. Consult IAEA GS-G-3.1, paras 6.78–6.84 [2], for guidance on implementation of this requirement.
6.18 Improvement plans shall include plans for the provision of adequate resources. Actions for improvement shall be monitored through to their completion and the effectiveness of the improvement shall be checked.
No corresponding requirement.
ASME NQA-1 users should address the requirement to provide adequate resources for improvement activities, to monitor improvement actions and to check the effectiveness of improvements. Consult IAEA GS-G-3.1, paras 6.78–6.84 [2], for guidance on implementation of this requirement.
TABLE 2. EXTENT TO WHICH ASME NQA-1 ADDRESSES IAEA GS-R-3 REQUIREMENTS (cont.)
IAEA-GS-R-3 para. No.
IAEA GS-R-3 requirementNotes to aid usersof ASME NQA-1
55
.
9 14 16
6-3
00 D
ocum
ent C
hang
es
7-1
00 B
asic
7-2
00 S
uppl
ier E
valu
atio
n an
d Se
lect
ion
7-3
00 B
id E
valu
atio
n
7-4
00 C
ontro
l of S
uppl
ier-
Gen
erat
ed
Doc
umen
ts
7-5
00 A
ccep
tanc
e of
Item
or S
ervi
ce
7-6
00 C
ontro
l of S
uppl
ier N
onco
nfor
man
ces
7-7
00 a
nd 7
-800
8-1
00 B
asic
8-2
00 a
nd 8
-300
9 C
ontro
l of S
peci
al P
roce
sses
9-1
00 to
9-4
00
10-
100
Basi
c
10-
200
Insp
ectio
n R
equi
rem
ents
10-
300
to 1
0-80
0
11-
100
Basi
c
11-
200
to 1
1-60
0
12-
100
Basi
c
12-
200
Sele
ctio
n
12-
300
and
12-4
00
13-
100
Basi
c
13-
200
Spec
ial R
equi
rem
ents
13-
300
Proc
edur
es
13-
400
to 1
3-60
0
14
Insp
ectio
n, T
est a
nd O
pera
ting
Stat
us 1
4-10
0 Ba
sic
15-
100
Basi
c
15-
200
Iden
tific
atio
n
15-
300
Segr
egat
ion
15-
400
Dis
posi
tion
16
Cor
rect
ive
Actio
n 1
6-10
0 Ba
sic
17-
100
Basi
c
17-
200
Gen
erat
ion
of R
ecor
ds
17-
300
Auth
entic
atio
n of
Rec
ords
17-
400
Cla
ssifi
catio
n
17-
500
to 1
7-60
0
17-
700
Ret
entio
n
17-
800
Mai
nten
ance
of R
ecor
ds
18-
100
Basi
c
18-
200
Sche
dulin
g
18-
300
Prep
arat
ion
18-
400
and
18-5
00
18-
600
Res
pons
e
18-
700
Follo
w-u
p Ac
tion
18-
800
Rec
ords
x
x x x x x x x
x x x x x x x x x x x x x x x x x x
x x x x x
IAEA
GS-
R-3
2. M
anag
emen
t Sys
tem
ASME NQA-1
nt l
4. R
esou
rce
Man
agem
ent
5. P
roce
ss
Impl
emen
tatio
n6.
Mea
sure
men
t, As
sess
men
t and
Im
prov
emen
t
fo
B
3. M
anag
emen
t Res
pons
ibili
ty
15 Control of
Nonconforming Items
17 Quality Assurance Records
18 Audits
7 Control of Purchased Items and
Services
8 Identifi-
cation and Control of
Items
10 Inspection
11 Test
Control
12 Control of
Measuring and Test Equipment
13 Handling, Storage,
Shipping
APPEN 3 AND THOSE OF ASME NQA-1
5
1-1
00 B
asic
1-2
00 S
truct
ure
and
Res
pons
ibili
ty
1-3
00 In
terfa
ce C
ontro
l
2-1
00 B
asic
2-2
00 In
doct
rinat
ion
and
Trai
ning
2-3
00 Q
ualif
icat
ion
Req
uire
men
ts
2-4
00 R
ecor
ds o
f Qua
lific
atio
n
2-5
00 R
ecor
ds
3-1
00 to
3-7
00
3-8
00 S
oftw
are
Des
ign
Con
trol
3-9
00 D
ocum
enta
tion
and
Rec
ords
4-1
00 B
asic
4-2
00 C
onte
nt o
f the
Pro
cure
men
t Doc
umen
ts
4-3
00 P
rocu
rem
ent D
ocum
ent R
evie
w
4-4
00 P
rocu
rem
ent D
ocum
ent C
hang
es
5 In
stru
ctio
ns, P
roce
dure
s an
d D
raw
ings
5-1
00 B
asic
6-1
00 B
asic
6-2
00 D
ocum
ent C
ontro
l
General requirements (2.1-2.4) x x
Safety Culture (2.5)
Grading the application of management system (2.6-2.7) x Documentation of the management system (2.8-2.10) x x x
Management commitment (3.1-3.5)
Satisfaction of interested parties (3.6)
Organizational policies (3.7)
Planning (3.8-3.11) x Responsibility and authority for the management system (3.12-3.14) x x
Provision of resources (4.1-4.2) x
Human resources (4.3-4.4) x x x Infrastructure and the working environment (4.5) x
Developing processes (5.1-5.5) x x
Process management (5.6-5.10) x x x x x Generic management system processes (5.11-5.29) x x x x x x x x
Monitoring and measurement (6.1) x
Self-assessment (6.2) x
Independent assessment (6.3-6.6) x x
6 Docume
Contro
Correlation matrix r IAEA GS-R-3 users
lank = no correlationGrey = no correlation
X = correlation
1 Organization
2 Quality Assurance Program
3 Design Control
4 Procurement
Document Control
DIX I: CORRELATION BETWEEN THE REQUIREMENTS OF IAEA GS-R-
57
Management system review (6.7-6.10) x Non-conformances and corrective and preventive actions (6.11-6.16) x x x x x x x x x
Improvement (6.17-6.18) x
1 2012-05-18
Gen
eral
requ
irmen
ts (2
.1-2
.2)
Gen
eral
requ
irmen
ts (2
.3)
Gen
eral
requ
irmen
ts (2
.4)
Saf
ety
Cul
ture
(2.5
)
Gra
ding
the
appl
icat
ion
of m
anag
emen
t s
yste
m (2
.6-2
.7)
Doc
umen
tatio
n of
the
man
agem
ent s
yste
m
(2.8
-2.1
0)
Man
agem
ent c
omm
itmen
t (3.
1)
Man
agem
ent c
omm
itmen
t (3.
2-3.
4)
Man
agem
ent c
omm
itmen
t (3.
5)
Sat
isfa
ctio
n of
inte
rest
ed p
artie
s (3
.6)
Org
aniz
atio
nal p
olic
ies
(3.7
)
Pla
nnin
g (3
.8-3
.9)
Pla
nnin
g (3
.10-
3.11
)
Res
pons
ibilit
y an
d au
thor
ity fo
r the
m
anag
emen
t sys
tem
(3.1
2)
Res
pons
ibilit
y an
d au
thor
ity fo
r the
m
anag
emen
t sys
tem
(3.1
3)
Res
pons
ibilit
y an
d au
thor
ity fo
r the
m
anag
emen
t sys
tem
(3.1
4)
Pro
visi
on o
f res
ourc
es (4
.1-4
.2)
Hum
an re
sour
ces
(4.3
-4.4
)
Infra
stru
ctur
e an
d th
e w
orki
ng e
nviro
nmen
t (4
.5)
Dev
elop
ing
proc
esse
s (5
.1)
Dev
elop
ing
proc
esse
s (5
.2)
Dev
elop
ing
proc
esse
s (5
.3-5
.5)
Pro
cess
man
agem
ent (
5.6)
Pro
cess
man
agem
ent (
5.7-
5.10
)
Gen
eric
man
agem
ent s
yste
m p
roce
sses
(5
.11)
Con
trol o
f Doc
umen
ts (5
.12-
5.13
)
Con
trol o
f Pro
duct
s (5
.14-
5.20
)
Con
trol o
f Rec
ords
(5.2
1-5.
22)
Pur
chas
ing
(5.2
3-5.
25)
Com
mun
icat
ion
(5.2
6-5.
27)
Man
agin
g O
rgan
izat
iona
l Cha
nge
(5.2
8)
Man
agin
g O
rgan
izat
iona
l Cha
nge
(5.2
9)
Mon
itorin
g an
d m
easu
rem
ent (
6.1)
Sel
f-ass
essm
ent (
6.2)
Inde
pend
ent a
sses
smen
t (6.
3-6.
6)
Man
agem
ent s
yste
m re
view
(6.7
)
Man
agem
ent s
yste
m re
view
(6.8
-6.1
0)
Non
-con
form
ance
s an
d co
rrect
ive
and
pre
vent
ive
actio
ns (6
.11-
6.15
)
Non
-con
form
ance
s an
d co
rrect
ive
and
pre
vent
ive
actio
ns (6
.16)
Impr
ovem
ent (
6.17
-6.1
8)
1 Organization x x x x x x x x x x x
2 Quality Assurance Program x x x x x x x x x x x x x x
3 Design Control x x
4 Procurement Document Control x x x
5 Instructions, Procedures and Drawings x x x x
6 Document Control x x x x
7 Control of Purchased Items and Services x x x x
8 Identification and Control of Items x
9 Control of Special Processes
10 Inspection x x
11 Test Control x
12 Control of Measuring and Test Equipment x
13 Handling, Storage, Shipping x
14 Inspection, Test and Operating Status x
15 Control of Nonconforming Items X
16 Corrective Action x X
17 Quality Assurance Records x x
18 Audits x
ASM
E N
QA
-1
Correlation matrix for ASME NQA-1 users
Blank = no correlation Grey = no correlation
X = correlation
IAEA GS-R-32. Management System
4. Resource Management 6. Measurement, Assessment and Improvement5. Process Implementation3. Management Responsibility
APPENDIX II: CORRELATION BETWEEN THE REQUIREMENTS OF ASME NQA-1 AND THOSE OF IAEA GS-R-3
TEAM VERSIONRev. C 1 Dec. 8, 2008
58
REFERENCES
[1] INTERNATIONAL ATOMIC ENERGY AGENCY, The Management System for Facilities and Activities, IAEA Safety Standards Series No. GS-R-3, IAEA, Vienna (2006).
[2] INTERNATIONAL ATOMIC ENERGY AGENCY, Application of the Management System for Facilities and Activities, IAEA Safety Standards Series No. GS-G-3.1, IAEA, Vienna (2006).
[3] INTERNATIONAL ATOMIC ENERGY AGENCY, The Management System for Nuclear Installations, IAEA Safety Standards Series No. GS-G-3.5, IAEA, Vienna, (2009).
[4] AMERICAN SOCIETY OF MECHANICAL ENGINEERS, Quality Assurance Requirements for Nuclear Facility Applications, ASME NQA-1-2008, ASME, New York (2008), with Addenda to ASME NQA-1-2008, ASME NQA-1a-2009, ASME, New York (2009).
[5] INTERNATIONAL ATOMIC ENERGY AGENCY, Management Systems: Comparison between IAEA GS-R-3 and ISO 9001:2008, IAEA Safety Reports Series No. 69, IAEA, Vienna (2012).
[6] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Assurance for Safety in Nuclear Power Plants and other Nuclear Installations, Code and Safety Guides Q1–Q14, Safety Series No. 50-C/SG-Q, IAEA, Vienna (1996).
[7] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Assurance Standards: Comparison between IAEA 50-C/SG-Q and ISO 9001:1994, IAEA-TECDOC-1182, IAEA, Vienna (2000).
[8] INTERNATIONAL ATOMIC ENERGY AGENCY, Quality Standards: Comparison between IAEA 50-C/SG-Q and ISO 9001:2000, Safety Reports Series No. 22, IAEA, Vienna (2002).
59
.
CONTRIBUTORS TO DRAFTING AND REVIEW
Agarwal, D. Department of Energy, United States of America
Beher, M. AREVA NP GmbH, Germany
Boogaard, J.P. International Atomic Energy Agency
Clark, C.R. International Atomic Energy Agency
Dahlgren Persson, K. International Atomic Energy Agency
Danielson, B.G. Department of Energy, United States of America
Dua, S. Atomic Energy of Canada Ltd, Canada
Dusic, M. International Atomic Energy Agency
Feige, G. International Atomic Energy Agency
Hille, M. AREVA NP GmbH, Germany
Kerhoas, A. International Atomic Energy Agency
Majola, J. International Atomic Energy Agency
Marden, C. Energy Solutions, United States of America
Pribac, F. Krško Nuclear Power Plant, Slovenia
Sabate Farnos, R. Westinghouse Technology Services, Spain
Sowder, K. US-ITER Organization, United States of America
Vincze, P. International Atomic Energy Agency
Watson, A.G. Consultant, United Kingdom
Consultants Meetings
Vienna, Austria: 8–12 December 2008, 30 March – 3 April 2009, 13–15 July 2009
61
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11-39221
IAEA SAFETY STANDARDS AND RELATED PUBLICATIONS
IAEA SAFETY STANDARDS
Under the terms of Article III of its Statute, the IAEA is authorized to establish or adopt standards of safety for protection of health and minimization of danger to life and property, and to provide for the application of these standards.
The publications by means of which the IAEA establishes standards are issued in the IAEA Safety Standards Series. This series covers nuclear safety, radiation safety, transport safety and waste safety. The publication categories in the series are Safety Fundamentals,Safety Requirements and Safety Guides.
Information on the IAEA’s safety standards programme is available at the IAEA Internet site
http://www-ns.iaea.org/standards/
The site provides the texts in English of published and draft safety standards. The texts of safety standards issued in Arabic, Chinese, French, Russian and Spanish, the IAEA Safety Glossary and a status report for safety standards under development are also available. For further information, please contact the IAEA at PO Box 100, 1400 Vienna, Austria.
All users of IAEA safety standards are invited to inform the IAEA of experience in their use (e.g. as a basis for national regulations, for safety reviews and for training courses) for the purpose of ensuring that they continue to meet users’ needs. Information may be provided via the IAEA Internet site or by post, as above, or by email to Official.Mail@iaea.org.
RELATED PUBLICATIONS
The IAEA provides for the application of the standards and, under the terms of Articles III and VIII.C of its Statute, makes available and fosters the exchange of information relating to peaceful nuclear activities and serves as an intermediary among its Member States for this purpose.
Reports on safety and protection in nuclear activities are issued as Safety Reports, which provide practical examples and detailed methods that can be used in support of the safety standards.
Other safety related IAEA publications are issued as Radiological Assessment Reports, the International Nuclear Safety Group’s INSAG Reports, Technical Reports and TECDOCs. The IAEA also issues reports on radiological accidents, training manuals and practical manuals, and other special safety related publications.
Security related publications are issued in the IAEA Nuclear Security Series.The IAEA Nuclear Energy Series consists of reports designed to encourage and assist
research on, and development and practical application of, nuclear energy for peaceful uses. The information is presented in guides, reports on the status of technology and advances, and best practices for peaceful uses of nuclear energy. The series complements the IAEA’s safety standards, and provides detailed guidance, experience, good practices and examples in the areas of nuclear power, the nuclear fuel cycle, radioactive waste management and decommissioning.
RELATED PUBLICATIONS
www.iaea.org/books
MANAGEMENT SYSTEM STANDARDS: COMPARISON BETWEEN IAEA GS-R-3 AND ISO 9011:2008Safety Reports Series No. 69STI/PUB/1529 (55 pp.; 2012)ISBN 978-92-0-120710-4 Price: €29.00
THE MANAGEMENT SYSTEM FOR FACILITIES AND ACTIVITIESIAEA Safety Standards Series No. GS-R-3STI/PUB/1252 (39 pp.; 2006)ISBN 92–0–106506–X Price: €25.00
APPLICATION OF THE MANAGEMENT SYSTEM FOR FACILITIES AND ACTIVITIESIAEA Safety Standards Series No. GS-G-3.1STI/PUB/1253 (123 pp; 2006)ISBN 92-0-106606-6 Price: €31.00
THE MANAGEMENT SYSTEM FOR NUCLEAR INSTALLATIONSIAEA Safety Standards Series No. GS-G-3.5STI/PUB/1392 (139 pp; 2009)ISBN 978-92-0-103409-0 Price: €35.00
MANAGEMENT OF CONTINUAL IMPROVEMENT FOR FACILITIES AND ACTIVITIES: A STRUCTURED APPROACHIAEA TECDOC Series No. 1491IAEA-TECDOC-1491 (61 pp; 2006)ISBN 92-0-102906-3 Price: €15.00
KEY PRACTICAL ISSUES IN STRENGTHENING SAFETY CULTUREINSAG Series No. 15STI/PUB/1137 (25 pp; 2002)ISBN 92–0–112202–0 Price: €12.50
THE MANAGEMENT SYSTEM FOR TECHNICAL SERVICES IN RADIATION SAFETYIAEA Safety Standards Series No. GS-G-3.2STI/PUB/1319 (51 pp; 2008)ISBN 978-92-0-100308-9 Price: €25.00
THE MANAGEMENT SYSTEM FOR THE PROCESSING, HANDLING AND STORAGE OF RADIOACTIVE WASTEIAEA Safety Standards Series No. GS-G-3.3 STI/PUB/1329 (69 pp; 2006)ISBN 978-92-0-102008-6 Price: €25.00
S a f e t y R e p o r t s S e r i e s N o. 7 0
M a n a g e m e n t S y s t e m S t a n d a r d s :
C o m p a r i s o n b e t w e e n I A E A G S - R - 3 a n d
A S M E N Q A - 1 - 2 0 0 8 a n d N Q A - 1 a - 2 0 0 9 A d d e n d a
This Sa fe t y Repor t compares the r equ i r ements o f IAEA Sa fe t y S tandards Se r i es No . GS -R -3 , The Management Sys tem fo r Fac i l i t i e s and Ac t i v i t i e s , and the Amer i can Soc i e t y o f Mechan ica l Eng inee rs ( A S M E ) Q u a l i t y A s s u r a n c e R e q u i r e m e n t s f o r Nuc lea r Fac i l i t y App l i ca t i ons (ASME NQA-1 -2008 , NQA -1a -2009) . I t i den t i f i e s the s im i l a r i t i e s and d i f f e rences be tween them and p rov i des i n fo rma -t i on and gu idance to ass i s t an o rgan i za t i on i n mee t ing the r equ i rements o f bo th s tandards .
INTERNATIONAL ATOMIC ENERGY AGENCYVIENNA
ISBN 978–92–0–120810–1ISSN 1020–6450